UAB Policy on Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations - IRB POL021

Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.

UAB Policy on Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations

POLICY STATEMENT

Under UAB policy, clinical investigations will undergo review and performance in accordance with federal regulations of the Food and Drug Administration pertaining to human subjects protections and investigational drugs, biological products, devices or test articles. The UAB IRB will make an assessment of whether or not a clinical investigation must be conducted under an investigational new drug (IND; 21 CFR Part 312) application or investigational device exemption (IDE; 21 CFR Part 812) and, when applicable, will determine that a valid IND or IDE is present before approving the research. Investigators are responsible for supplying sufficient information to the IRB to make its assessment. (See also: Procedure[s] to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to [PRO121Pharmacy] [PRO141Devices], Inventory Control, and Documentation.)

For studies involving investigational devices that are not exempt from the IDE requirements, do not have an IDE, and for which the sponsor claims is not a significant risk device, the IRB will make an assessment of whether the device is a significant risk device. When a study claims to involve a non-significant risk device, the sponsor through the investigator must supply the IRB with an explanation of its claim. The IRB will assess the risk status of the device according to the definition of significant risk device in FDA regulations. Whenever the IRB assessment categorizes a claimed non-significant risk device as a significant risk device, it will notify the investigator and, where applicable, the sponsor. In such circumstances, the clinical investigation may not be performed at UAB without an effective FDA IDE application for the device investigation or other FDA approval.

Whenever an investigator holds the IND or IDE for investigational uses of test articles, the investigator acquires all the responsibility of a sponsor of the clinical investigation under the IND or IDE. The investigator status changes to sponsor-investigator (21 CFR 312.3 for drugs, 31 see GUI307; 21 CFR 812.3 for devices, see GUI306). Sponsor responsibilities may be delegated to another person only by written agreement. Regulatory monitoring for clinical investigations performed by an investigator holding an IND/IDE will include monitoring sponsor responsibilities. For studies by an investigator holding an IND/IDE a member of the OIRB regulatory compliance staff will conduct a pre-startup monitoring visit to ensure an adequate plan to meet sponsor responsibilities is in place. The IRB will not issue approval until receipt of documentation of pre-study start up visit has satisfactorily completed.

Approved on March 1, 2010, by:

Richard B. Marchase, PhDVice President for Research and Economic Development